Testosterone plus finasteride in older men
Combined testosterone and finasteride in older males increases bone mineral density (BMD) and decreases prostate hypertrophy. This is a very interesting study with significant implications for older men who have low testosterone levels and who are concerned about the possibility of prostate hypertrophy. Not covered in this study, but another potentially significant result from the combination of testosterone and finasteride, would be increased hair growth (or stopping hair loss) in older males as a result of the finasteride's ability to block dihydrotestosterone (DHT). See: J Clin Endocrinol Metab. 2004 Feb;89(2):503-10, Amory JK and others, PMID: 14764753. A group of men aged 65 years or older were given either 200-mg testosterone ethanate injection (T) plus placebo pills, T plus finasteride (F) 5-mg day pills (T+F), or placebo injection plus placebo pills. The men were followed for 36 months with serial measurements of BMD via dual-energy X-ray absorptiometry (DXA), PSA tests and measurement of prostate size. Fifty men completed the protocol with the following results: T or T+F therapy gave approximately a 10% increase in lumbar spine BMD compared to baseline and about 2.5% increase in the hip. Placebo results showed approximately 1% and no increase in the spine and hip, respectively over the same time period. Additionally, PSA results increased significantly in only the T group while there was significantly less increase in prostate size in the T+F group. The authors conclude: "These results demonstrate that T therapy in older men with low serum T increases vertebral and hip BMD over 36 months, both when administered alone and when combined with F. This finding suggests that dihydrotestosterone is not essential for the beneficial effects of T on BMD in men. In addition the concomitant administration of F with T appears to attenuate the impact of T therapy on prostate size and PSA and might reduce the chance of benign prostate hypertrophy or other prostate-related complication in older men on T therapy." So, the addition of F with T therapy seems to be a very beneficial addition with three possible improvements: Decreased prostate enlargement, decreased PSA levels and the possibility of improved hair growth (or less hair loss). More on other studies using F follows.
Finasteride for benign prostate hyperplasia (BPH). See: Prostate 1993;22(4):291-9, no authors listed, PMID: 7684524. Giving 1 or 5 mg F to 750 patients with BPH for 12 months and comparing to placebo gave the following results: Either 1 or 5-mg F gave similar results which were 62% decrease in dihydrotestosterone, 46% decrease in PSA, prostate volume reduced by 22%, maximum urinary flow rate increased by 1.7 ml/sec and only in the 5-mg group was there a decrease in total urinary symptoms scores. Additionally, the F was well tolerated. So, the authors stated: "We conclude that finasteride is an effective medical therapy for a significant proportion of patients with BPH. It is interesting that either 1- or 5-mg dosages of F work on everything but urinary symptoms, so if there are no urinary symptoms, there would appear to be no need for the higher dosage. This could be significant because as I'll point out later, the 1-mg dosage of F also appears adequate to treat male pattern baldness. Here are some other studies and their findings concerning BPH treated with F. Long-term BPH results, first study. J Urol. 2004 Mar;171(3):1194-1198, Rochrborn CG and others, PMID: 14767299. This study reports 6-year findings (2-year open extension of a previous 4-year study) for 3,016 patients treated with placebo or 5-mg F daily to test effectiveness regarding acute urinary retention (AUR) and BPH. There was a sustained decrease in the incidence of AUR and/or BPH related surgery in men with BPH and enlarged prostates. Additionally, men in the 4-year placebo group who switched over for the additional 2 years of 5-mg F, had similar results to the men in the 6-year group. Long-term BPH results, second study. Urology. 2003 Feb;61(2):354-8, Lam JS and others, PMID: 12597947. A general summary of this study shows that properly selected men appear to respond favorably over a ten-year period to 5-mg daily F therapy for BPH and enlarged prostates. Early cancer diagnosis in F-treated BPH patients, first study. Anticancer Res. 2003 Jan-Feb;23(1B):693-6, Tarle M and others, PMID: 12680169. A general summary of this study is that men who have the greatest drop (near 50%) in PSA levels appear to be at minimal or no risk of developing prostate cancer early in their treatment of BPH with F. Men whose PSA levels drop less than 50% appear to be at greater risk and thus should have serial assessments of total and free PSA as well as other diagnostic testing to rule out prostate cancer development. Early cancer diagnosis in F-treated BPH patients, second study. Urology. 2002 Sep;60(3):464-8, Kaplan SA and others, PMID: 12350485. This study on men who started F therapy with PSA greater than 4 ng/ml and a previous negative prostate biopsy had similar results to the Tarle M and others study. Basically, if men had a 50% or greater reduction in PSA, there was no prostate cancer diagnosed. However, if that reduction was 33% or less, then there was a much higher chance of developing prostate cancer. Prostate cancer prevention trial. See two papers on this topic: J Urol. 2004 Feb:171(2 Pt 2):S1507;discussion S8, Higgins B, Thompson IM, PMID: 14713747. And, N Engl J Med. 2003 Jul 17;349(3):215-24, Thompson IM and others, PMID: 12824459. These papers cover a very large trial including 18,882 men in which there was a 24.8% reduction in prostate cancer with F therapy. The authors do note that higher grade Gleason tumors were noted in more of the men in the F group and those men had a higher incidence of sexual side effects. But they concluded: "Finasteride prevents or delays the appearance of prostate cancer, but this possible benefit and a reduced risk of urinary problems must be weighed against sexual side effects and the increased risk of high-grade prostate cancer.
Finasteride to treat male androgenetic alopecia (male patttern hair loss). J Investig Dermatol Symp Proc. 2003 Jun;8(1):20-3, Shapiro J and Kaufman KD, PMID: 12894990. Read this study for a summary of the peer-reviewed literature on the topic of F for treatment of men with AGA (adrogenetic alopecia). The authors summarize that the 5-mg daily dose of F originally used to treat BPH has been reduced to 1-mg daily to treat AGA, both with excellent safety profiles. Another review study. Eur J Dermatol. 2001 Jul-Aug;11(4):332-4, Whiting DA, PMID: 11399540. This abstract points out that F can produce visible hair growth in 66% of men with mild to moderate alopecia, and can stop hair loss in 91% of patients, and if discontinued, men again will lose hair. The author notes, "The proven preservative effect of finasteride, in addition to its restorative effect, is a strong indication for prescribing it in early cases of androgenetic alopecia before much hair has been lost." Long term results (5 year) using 1 mg F. Eur J Dermatol. 2002 Jan-Feb;12(1):38-49, Finasteride Male Pattern Hair Loss Study Group, PMID: 11809594. This 5-year study included 1,215 men and showed durable improvements in scalp hair over five years versus placebo. Additionally, F was well tolerated and no new safety concerns were identified during the study. Results from a 2-year study. J Am Acad Dermatol. 1998 Oct;39(4 Pt 1):578-89, Kaufman KD and others, PMID: 9777765.This study involved 1,215 men for two years who were taking 1-mg F daily. Once again hair growth improved compared to placebo and hair loss was slowed with minimal adverse side effects.
Summary. It can be tricky to come to hard and fast solutions based upon research that deals with drugs used for somewhat different purposes. In these studies we have younger men being treated with 1-mg daily doses of F for hair loss, we have older men being treated with 5-mg daily doses of F for BPH and/or prostate symptoms. Additionally, the men in the first study were treated for low testosterone levels by giving them both testosterone and F to see if this combination could prevent prostatic hypertrophy and retain or induce increased BMD. My primary concern on this Website is men with osteoporosis--or those wishing to prevent osteoporosis--so I want to mainly consider the possibility of adding F to testosterone therapy. Many of us are taking testosterone injections, using the patch, etc., and may wish to avoid or treat BPH and/or hair loss. There appears to be considerable evidence for the long-term safety and effectiveness of F for the various conditions it treats. Thus, adding it to testosterone therapy should also be safe and could offer additional benefits while maintaining the main testosterone benefit we use it for: Increasing BMD. Because I'm currently dealing with adrogenetic alopecia, I will be talking to my physician about adding F to my treatment regimen. Since I have no prostate signs or symptoms, the 1-mg/day dose would appear to be what is needed. If that stops the hair loss and allows the continual increase in BMD that I have had since starting testosterone and alendronate therapy, that would be great. If it additionally slows prostate enlargement, that would be an added benefit. Regular check ups to rule out prostate cancer appear warranted for all older men whether they are taking F or not. There is evidence to suggest added visits during the first year of therapy, especially if your PSA is somewhat elevated already, with biopsy or careful monitoring possibly indicated if your PSA level doesn't drop approximately 50% after starting F therapy.